S-1/A: Profusa Amends PIPE, Details Bitcoin Strategy Amid Going Concern

Profusa, Inc. filed an S-1 amendment detailing a revised $22.2 million PIPE financing, its new Bitcoin treasury strategy, and ongoing substantial doubt about its ability to continue as a going concern.

Summary

• Profusa, Inc. (formerly NorthView Acquisition Corporation) filed an Amendment No. 1 to its S-1 Registration Statement for the resale of up to 222,222,222 shares of Common Stock by Ascent Partners Fund LLC.
• The shares are issuable upon conversion of Ascent Notes with an aggregate principal value of $22,222,222.
• The PIPE Subscription Agreement was amended on August 25, 2025, structuring the notes into four tranches, with an initial $10,000,000 tranche already closed on July 11, 2025.
• Profusa has adopted a Bitcoin treasury strategy, having purchased $1.0 million of Bitcoin (8.53 Bitcoins) as of the filing date. Proceeds from a $100 million Committed Equity Facility (ELOC) with Ascent will be used for Bitcoin purchases, provided the cash balance exceeds $5 million.
• The company continues to have substantial doubt about its ability to continue as a going concern, citing recurring losses and a working capital deficit of approximately $63.2 million as of June 30, 2025.
• Profusa is developing biointegrated sensors: the Lumee Oxygen Platform (CE Mark approved in EU, US FDA marketing authorization planned for late 2026) and the Lumee Glucose Platform (clinical trials ongoing, EU launch expected 2025, US approval late 2026 or early 2027).
• The company reported a net loss of $5.1 million for the six months ended June 30, 2025, and $9.2 million for the year ended December 31, 2024.
• Material weaknesses in internal control over financial reporting were identified, including issues with segregation of duties and valuation of convertible notes and warrants.

Sentiment

Score: 3

Explanation: The company faces severe financial challenges, including substantial doubt about its ability to continue as a going concern, significant losses, and a Nasdaq delisting. While it has secured PIPE financing and an ELOC, and its product pipeline shows promise, the immediate financial health is precarious. The Bitcoin treasury strategy introduces additional volatility and risk.

Positives

• Successful completion of the business combination on July 11, 2025, with Profusa (CA) becoming a wholly-owned subsidiary of the newly renamed Profusa, Inc. (DE).
• Secured a PIPE financing facility with Ascent Partners Fund LLC for up to $22,222,222 in senior secured convertible notes, with an initial $10,000,000 tranche already funded.
• Established a Committed Equity Facility (ELOC) with Ascent for up to $100,000,000, providing a potential source of future capital.
• The Lumee Oxygen Platform has received CE Mark approval in the EU and is targeting US FDA marketing authorization by late 2026.
• The Lumee Glucose Platform has generated proof-of-concept clinical data from 54 diabetes subjects, showing a potential mean absolute relative difference (MARD) of approximately 11% with up to nine months of functionality post-injection, and zero device-related serious adverse events (SAE).
• Profusa holds a significant intellectual property portfolio with 20 issued U.S. patents and 80 rest-of-world patents, expiring between March 2030 and January 2040.
• The company is actively pursuing a joint venture in the Asia Pacific region with Tasly Holding Group Co. Ltd. or its affiliates, which could provide $6 million in funding.
• Management has hired a new CFO with significant experience in financial reporting and internal controls to address identified material weaknesses.

Negatives

• Substantial doubt exists about the company's ability to continue as a going concern, despite recent financing, due to recurring losses and a significant working capital deficit of approximately $63.2 million as of June 30, 2025.
• The company incurred significant net losses: $2.3 million in Q2 2025, $5.1 million in H1 2025, and $9.2 million in FY 2024.
• Cash and cash equivalents were critically low at $0.1 million as of June 30, 2025.
• The PPP Loan 2 of $1.3 million is in default due to non-payment, incurring a 1% annual interest rate and late penalties.
• Promissory notes totaling $940,000 to founders and insiders are past due or payable on demand, with the company currently in default.
• Identified material weaknesses in internal control over financial reporting, including segregation of duties in journal entries and procurement, and insufficient controls for reviewing and reconciling accounts payable and accrued liabilities.
• The company's Bitcoin treasury strategy exposes it to high volatility, liquidity risks, and counterparty risks, and the accounting treatment for Bitcoin could increase financial result volatility.
• The company will not receive any proceeds from the resale of 222,222,222 shares by the Selling Stockholder (Ascent Partners Fund LLC) under this prospectus.
• The company was delisted from Nasdaq on December 27, 2024, and its securities are now quoted on the OTC Market, which can negatively impact liquidity and investor confidence.
• The company has a significant accumulated deficit of $130.022 million as of June 30, 2025.

Risks

• Substantial doubt about the ability to continue as a going concern, which may hinder obtaining further financing.
• Limited operating history and anticipated significant losses for several years as products are commercialized and developed.
• Operating in a highly competitive market and facing competition from large, well-established companies with significant resources.
• Subject to a variety of risks due to international operations that could adversely affect business, operations, or profitability and operating results.
• Consumer confusion about product features and technology could lead consumers to purchase competitive products or conflate adverse events with Profusa's products.
• Commercialization of the Lumee Oxygen Platform is expected to generate nearly all commercial revenue until regulatory approval for additional products.
• Dependence on third-party suppliers and outsourcing makes the company vulnerable to supply disruptions, suboptimal quality, noncompliance, and/or price fluctuations.
• No guarantee that the FDA will grant 510(k) clearance or PMA approval of products, and failure to obtain necessary clearances or approvals would adversely affect business growth.
• Inability to successfully complete pre-clinical studies or clinical trials necessary to support additional PMA, De Novo, or 510(k) applications or supplements could impair business.
• Products may cause or contribute to adverse medical events or be subject to failures or malfunctions that are required to be reported to the FDA, leading to sanctions or recalls.
• Quality problems could lead to recalls or safety alerts, reputational harm, and could have a material adverse effect on business.
• Current or future products may be subject to product recalls even after receiving FDA clearance or approval.
• Changes to the regulatory landscape may impact the ability to obtain marketing authorization for future product developments.
• Failure to comply with laws, regulations, and contract requirements relating to reimbursement of health care goods and services may subject the company to penalties.
• Subject to complex and evolving U.S. and foreign laws and regulations and other requirements regarding privacy, data protection, and security.
• Cybersecurity risks and cyber incidents could result in the compromise of confidential data or critical data systems and give rise to potential harm to customers, remediation expenses, liability, and reputational damage.
• May become subject to claims of infringement or misappropriation of the intellectual property rights of others, which could prohibit shipping affected products or require licenses.
• Involvement in lawsuits to protect or enforce patents or the patents of licensors could be expensive, time-consuming, and unsuccessful.
• Inability to protect intellectual property rights throughout the world could materially negatively affect business.
• Failure to protect the confidentiality of trade secrets could materially adversely affect the value of technology.
• May need or choose to obtain licenses from third parties to advance research or allow commercialization of products, and there is no assurance such licenses would be obtained.
• Obtaining and maintaining patent protection depends on compliance with various procedural requirements, and patent protection could be reduced or eliminated for non-compliance.
• Inadequate patent term extension and/or data exclusivity for any product candidates developed as drug product candidates could materially harm business.
• Inability to successfully maintain effective internal control over financial reporting could adversely impact investor confidence and stock price.
• Environmental, social, and corporate governance (ESG) regulations, policies, and provisions may make the supply chain more complex and adversely affect customer relationships.
• Current uncertainty in domestic and global economic and political conditions makes it particularly difficult to predict product demand.
• Changes in financial accounting standards or practices or existing taxation rules or practices may cause adverse unexpected revenue and/or expense fluctuations.
• Failure to maintain an effective system of disclosure controls and internal control over financial reporting could impair ability to produce timely and accurate financial statements.
• Bitcoin treasury strategy exposes the company to various risks associated with Bitcoin, including high volatility, liquidity issues, and potential reclassification as a security.
• No assurance of compliance with Nasdaq continued listing standards, a failure of which could result in delisting.
• Future sales, or the perception of future sales, by Profusa shareholders in the public market could cause the market price for Profusa Common Stock to decline.
• The grant and future exercise of registration rights may adversely affect the market price of Profusa shares.
• Shares of Profusa Common Stock reserved for future issuance under the Equity Incentive Plan will become eligible for sale in the public market once issued.
• No current plans to pay cash dividends on Profusa Common Stock for the foreseeable future, so return on investment depends on stock price appreciation.
• Issuance of additional shares of common stock or other equity securities without approval would dilute ownership interests.
• Anti-takeover provisions in the amended and restated certificate of incorporation and under Delaware law could make an acquisition more difficult.
• Exclusive forum provisions could limit stockholders' ability to obtain a favorable judicial forum for disputes.
• May be subject to securities litigation, which is expensive and could divert management attention.

Future Outlook

The company anticipates continued significant losses for at least the next several years as it commercializes existing products and develops new ones. Expenses are expected to increase substantially due to building sales and marketing infrastructure, ongoing product development, clinical studies, intellectual property protection, attracting personnel, and public company operations. Future revenue generation is heavily dependent on successful product launches, timely regulatory approvals, maintaining clinical and economic value, effectively addressing competition, and establishing robust manufacturing and distribution channels. The company plans to launch Lumee Oxygen in Europe in early 2026 and seek US FDA marketing authorization by late 2026. Lumee Glucose is expected to launch in the EU in 2025 (subject to regulatory approval) and target US approval in late 2026 or early 2027. Profusa aims to expand its product portfolio to manage other chronic conditions and leverage its data streams for high-growth healthcare sectors like telemedicine and health and wellness coaching. Additional annual expenses are expected as a public company for compliance, insurance, investor relations, and administrative services. The company will require additional financing to fund its operations and planned growth beyond 12 months from June 30, 2025.

Management Comments

• "Management believes this liquidity [from initial PIPE tranche] has not alleviated the relevant conditions or events that raise substantial doubt about the Company’s ability to continue as a going concern within one year from the date the condensed consolidated financial statements are issued."
• "Management is targeting the European market (those jurisdictions that accept CE mark) for early launch for both Lumee Oxygen and Lumee Glucose."
• "We feel a difference between other insertable or implantable CGMs and Lumee Glucose, is that the latter can be simply inserted with a hypodermic needle and does not require a surgical implantation, similar to how pharmacists use these needles to administer flu shots and other vaccines."
• "It is our expectation to continue to make substantial investments in building its European and United States commercial infrastructure and enhancing existing products and developing new ones."
• "We expect that any proceeds received from sales of Common Stock to Ascent will be used solely for the purchase of Bitcoin (which can be used for debt repayment) provided that the Company’s cash balance on the date of the applicable sale exceeds $5.0 million."
• "Management has accrued estimated incremental legal costs which totals less than $0.1 million related to the matter."

Industry Context

The medical device industry, particularly for oxygen monitoring and continuous glucose monitoring (CGM), is intensely competitive and characterized by rapid technological change and new product introductions. There is a significant trend in healthcare towards technology solutions that enable real-time data collection to facilitate clinical decisions, shifting care from costly hospital and clinic settings to individuals' homes. The telemedicine market has seen substantial growth, doubling from $41 billion to over $80 billion between 2019 and 2021, with remote coaching platforms also experiencing significant expansion. Government initiatives, such as CMS implementing reimbursement codes for remote patient monitoring (RPM) for chronic conditions, further support this shift, potentially offering over $200 monthly per patient. The continuous glucose monitoring market is estimated at $2.8 billion in the U.S. and over $800 million in Europe by the end of 2024, while the oxygen monitoring market is over $2 billion in the U.S. and over $700 million in Europe. Profusa believes its technology can bridge the gap between highly specialized, high-cost clinical applications and broad, consumer-friendly solutions that currently offer limited clinical utility. The company faces strong competition from large, well-established publicly traded companies like Abbott, Medtronic, and Roche in the CGM space, and Siemens Healthineers, Perimed AB, and SenTec AG in oxygen monitoring, all of whom possess greater financial resources, established distribution networks, and extensive experience.

Comparison to Industry Standards

• Lumee Glucose's ability to provide continuous glucose monitoring with a single injection for several months is presented as an attractive alternative to frequent finger sticks required by standard glucometers or the need for weekly sensor replacements required by current short-term needle-type CGMs (e.g., Dexcom G6, Abbott Freestyle Libre 2, Medtronic Guardian Connect).
• Profusa's glucose platform has demonstrated potential for a mean absolute relative difference (MARD) of approximately 11% with up to nine months of functionality post-injection, which is significantly longer than the typical 7-14 day longevity of many current CGM sensors due to the foreign body response.
• The company believes its technological approach offers a lower cost of system and longer functionality lifetime compared to existing CGM solutions, which are often expensive and typically only covered by insurance for the most brittle Type 1 and Type 2 diabetes patients.
• Lumee Oxygen provides a new method for measuring tissue oxygen concentration in interstitial fluid without perturbing the tissue after initial injection, offering added value compared to current alternative technologies like transcutaneous oximetry (TCPO2) devices (e.g., Perimed AB, Radiometer Medical, SenTec AG).
• The Lumee Oxygen sensor can be placed at a target depth of 3-6mm beneath the skin, enabling monitoring of deeper tissues, which is an advantage over methods limited to superficial tissue layers.

Management Changes

Corporate Governance

Legal Proceedings

• Currently defending one litigation with a vendor, with estimated incremental legal costs of less than $0.1 million accrued.

Related Party Transactions

• Tasly Convertible Debt: $2.5 million outstanding as of June 30, 2025, from Tasly (International) Healthcare Investment & Development Company Limited (a shareholder of Profusa). The company is currently in default on this loan.
• Promissory Notes: $940,000 outstanding as of June 30, 2025, to founders and insiders, with some past due or payable on demand.
• APAC Joint Venture Term Sheet: Profusa is negotiating definitive agreements for a joint venture with Carbis Bay Limited, BC hSensor Limited, and Tasly (International) Healthcare Capital Company Limited (affiliates of Tasly Holding Group Co. Ltd.) to commercialize products in the Asia Pacific region. Tasly would purchase 60% of the JV for $6 million.
• Advances from Profusa (CA) to NorthView: $1,299,040 owed to Profusa as of June 30, 2025, due upon demand or completion of the Business Combination.
• Convertible Working Capital Promissory Note: $1,919,796 principal outstanding (fair value $10,288,111 as of June 30, 2025) with the Sponsor (NorthView Sponsor I, LLC). Repayment deferred to six months after closing.
• Administrative Services Agreement: NorthView paid its Sponsor $5,000 per month for services, terminated June 30, 2025. $50,000 relating to this fee was unpaid as of June 30, 2025.

Stakeholder Impact

• Shareholders: Potential for significant dilution from the conversion of convertible notes and warrants, as well as future equity raises. The Nasdaq delisting and 'going concern' doubt could negatively impact share price and liquidity. Milestone earnout shares offer potential upside but are conditional.
• Employees: The company's ability to attract and retain skilled personnel is critical for growth, but financial instability and ongoing losses pose risks. Management changes include a new CFO and directors.
• Customers (Healthcare Providers/Patients): Development of Lumee Oxygen and Lumee Glucose platforms aims to improve health outcomes for patients with critical limb ischemia and diabetes, offering new monitoring solutions. However, regulatory approval delays or product issues could impact availability and adoption.
• Suppliers/Creditors: The company's 'going concern' status and defaults on loans (e.g., PPP Loan 2, promissory notes) indicate heightened risk for creditors and suppliers. Dependence on third-party suppliers creates supply chain risks.
• Regulatory Bodies: The company is subject to extensive pre-market and post-market regulation by the FDA and other authorities. Failure to comply could lead to penalties, recalls, or restrictions.

Next Steps

• Continue clinical trials for Lumee Glucose.
• Seek US FDA marketing authorization for Lumee Oxygen (expected late 2026).
• Initiate commercialization of Lumee Oxygen in Europe (early 2026).
• Seek regulatory approval for Lumee Glucose in Europe (expected 2025).
• Target US FDA approval for Lumee Glucose (late 2026 or early 2027).
• Establish a joint venture for Asia Pacific markets with Tasly Holding Group Co. Ltd. or its affiliates, including receiving $6 million in funding.
• Remediate identified material weaknesses in internal control over financial reporting.
• Apply for forgiveness for PPP Loan 2.
• Address repayment of promissory notes to founders and insiders.
• Utilize proceeds from the Committed Equity Facility for Bitcoin purchases, subject to cash balance conditions.
• File a registration statement for the resale of certain Profusa Common Stock issuable to PIPE Investors upon conversion of PIPE Convertible Notes (amended filing date September 14, 2025).

Key Dates

Recommendation

The filing reveals severe financial distress, including substantial doubt about the company's ability to continue as a going concern, significant recurring losses, and critically low cash reserves. The Nasdaq delisting further exacerbates liquidity and investor confidence issues. While the company has secured some financing and has promising product development, the immediate risks and operational control weaknesses are overwhelming. The Bitcoin treasury strategy introduces additional, unnecessary volatility given the company's precarious financial state. Investors should consider selling to mitigate exposure to these high risks.

Keywords

Profusa, Biointegrated Sensors, Lumee Oxygen Platform, Lumee Glucose Platform, Continuous Glucose Monitoring, CGM, Peripheral Artery Disease, Critical Limb Ischemia, Diabetes Management, Medical Devices, Biotechnology, SEC Filing, S-1 Registration, PIPE Financing, Convertible Notes, Bitcoin Treasury, Going Concern, Nasdaq Delisting, Clinical Trials, FDA Approval, CE Mark, Intellectual Property, Healthcare Technology, Risk Factors, Corporate Governance, Capital Raise